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ISO 13485 Quality Management System for Medical Devices

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Iso 13485 Manual Procedures Iso 13485 2016 translated into plain english, use iso 13485 2016 to show that your organization is consistently capable of providing

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ISO 13485 ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out

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Quality Manual Authorized by: The site is certified to ISO 9001 and ISO 13485. The site holds certificates from BSI: FM547845 (9001) and FM547846 (13485).

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Includes a fully-customizable (MS Word) ISO 13485 Quality Manual, COMPLETE set of 27 QMS Procedures and 30 related forms all connected with a logical numbering system

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